Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with diabetes are afflicted with ED within 10 years of their diagnosis. Long-term poor glycemic control increases the risk ED. Although comparatively costly, advantages of CSII over other modes of insulin delivery include better glycemic control, fewer hypoglycemic episodes, and improved quality of life. In a previously published study, on CSII in T2DM, in our center, 83% of men reported an improvement in sexual function as a secondary endpoint. The current study is planned to further explore this finding.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jothydev's Diabetes and Research Centre
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Male T2DM patients with HbA1c < 9%

• Mild ED to Moderate ED as defined by International Index of Erectile Function (IIEF) questionnaire

• Able and willing to use insulin pumps for at least the duration of the study

Exclusion Criteria:

• Severe dysfunction in IIEF Score or duration of ED more than 3 years

• Heart failure (class II - IV) or unstable cardiovascular disease; poorly controlled blood pressure (systolic > 170 or < 90 mmHg or diastolic > 100 or < 50 mmHg) or orthostatic hypotension

• Medications: Substance abuse, anticancer and steroid therapy

• Sexual dysfunction in partner, lack of stable relationship.

• History of radical prostatectomy or pelvic surgery, significant penile deformities, penile implants, or history of stroke or spinal-cord trauma.